Treats all forms of parkinsonism (postencephalitic, arteriosclerotic, and idiopathic). ANDA 91630, held by Natco Pharma Ltd. Trihexyphenidyl Hydrochloride.
As of Nov 15, 2026, ANDA 91630 (Trihexyphenidyl Hydrochloride), held by Natco Pharma Ltd, was first approved by FDA on Nov 17, 2010, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Trihexyphenidyl HCl is indicated as an adjunct in the treatment of all forms of parkinsonism (postencephalitic, arteriosclerotic, and idiopathic). It is often useful as adjuvant therapy when treating these forms of parkinsonism with levodopa. Additionally, it is indicated for the control of extrapyramidal disorders caused by central nervous system drugs such as the dibenzoxazepines, phenothiazines, thioxanthenes, and butyrophenones.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 17, 2010 | Original application | Approved | None posted |
| Trihexyphenidyl Hydrochloride2MG · tablet;oral | Trihexyphenidyl Hydrochloride | Rx |
| Trihexyphenidyl Hydrochloride5MG · tablet;oral | Trihexyphenidyl Hydrochloride | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
